A Multicenter Study to Evaluate the Nutritional Suitability of Renastart

NCT02825784 | Completed

• 1 other identifier: NA-REN-072013-03
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

A multicenter, open label, uncontrolled study to evaluate the acceptability, tolerability, and nutritional suitability of a medical food (Renastart, Vitaflo International Ltd) specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD)

Conditions

Chronic Kidney Disease; Hyperkalemia

Keywords

potassium chronic kidney disease CKD children

Outcome Measures

Primary Outcomes (1)

• Change in serum potassium level

  To evaluate the nutritional suitability of Renastart, specifically in relation to management of hyperkalemia via blood tests

  Baseline, week 8, week 16

Secondary Outcomes (5)

• Change in height (cm)

  Baseline, week 8, week 16

• Change in mass (kg)

  Baseline, week 8, week 16

• Palatability

  Throughout the 16 weeks

• Gastrointestinal tolerance

  Throughout the 16 weeks

• Compliance

  Throughout the 16 weeks

Study Arms (1)

Renastart

EXPERIMENTAL

Compared to cows' milk and/or standard pediatric enteral feeds, Renastart has the following additional nutritional features that are beneficial in children with CKD: lower phosphorus, calcium and vitamin A. The powder presentation allows flexibility with dilutions to facilitate the provision of adequate energy and protein to support growth in children with CKD. For each subject, the recommended daily intake of Renastart is determined by the dietitian in collaboration with the local PI and primary nephrologist based on individual nutritional requirements, specifically dietary intake of potassium and serum potassium levels. Renastart is to be given by the clinician and based on clinical and nutritional needs. Standard preparation guidelines can be found on the Renastart label.

Dietary Supplement: Renastart

Interventions

Renastart DIETARY_SUPPLEMENT

Renastart: specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD).

Renastart

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 10 years or under at the time of enrolment into the study.
• Diagnosed with Chronic Kidney Disease
• Requirement for a low potassium diet, as evidence by elevated serum potassium levels (\> normal reference value which is 3.5-5.0 mmol/L)
• Requirement for a low potassium enteral formula to provide a minimum of 20% of daily energy (kcal) requirements. (calculated according to individual child's needs and according to local clinical practice)
• Written informed consent provided by parent/primary caregiver.
• Assent provided by child, if appropriate.

You may not qualify if:

• Receiving total parenteral nutrition (TPN).
• Intolerance or allergy to cow's milk or any other ingredients in Renastart.
• Prior intolerance of Renastart formula.
• Any disorders which in the investigator's opinion may cause significant gastrointestinal malabsorption.
• Liver failure.
• Active infection or presenting with any signs or symptoms of an infectious disease at screening.
• Concurrent enrollment into another clinical trial.

Sponsors & Collaborators

• Vitaflo International, Ltd: lead

Study Sites (3)

Universitatsklinikum Bonn

Bonn, Germany

Location

Universitatsklinikum Koln

Cologne, Germany

Location

Universitatsklinikum Essen

Essen, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperkalemia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bernd Hoppe

  Universitätsklinik Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: July 7, 2016
• Study Start: January 6, 2017
• Primary Completion: May 31, 2019
• Study Completion: October 31, 2019
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)